510(k) K140980 ยท BZD Ventilator, Non-Continuous (Respirator)
TI NASAL MASK
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Feb 10, 2015 |
| Received | Apr 16, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140980
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2022 | Philips Respironics, Inc. DreamWisp Nasal Mask with Over the Nose Cushion Open, Classified |
BZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.